There are many clinical conditions that require access to bone tissues, such as bone marrow. In some cases it is important to access and retrieve bone tissue and/or bone marrow for diagnosis or treatment of conditions such as but not limited to, osteoporosis, degenerative bone diseases, fractures, vertebral fractures, cancers of any type and hematologic disease of any origin. For example, it may be necessary to access bone tissues and/or bone marrow to obtain a sample or specimen for diagnostic testing.
In other cases it may be necessary to introduce a medicament or a therapeutic agent directly into bone tissue or bone marrow that may be useful to treat or ameliorate a clinical condition. For example, it may be necessary to treat diseases with bone marrow or stem cell transplants to restore functioning blood cells. Such conditions may include, but are not limited to, acute leukemia, brain tumors, breast cancer, Hodgkin's disease, multiple myeloma, neuroblastoma, non-Hodgkin's lymphomas, ovarian cancer, sarcoma and testicular cancer. In other cases, it may be necessary to treat conditions such as osteoporosis, degenerative bone disorders, or fractures by introducing a medicament into the bone or bone marrow.
Gaining access to bone and associated bone marrow for a small biopsy specimen and/or aspiration of a larger quantity of bone marrow and/or to introduce a medicament may be difficult, traumatic and occasionally dangerous, depending on each selected target area for harvesting bone and/or associated bone marrow, operator expertise and patient. Currently available devices and techniques for gaining access to a bone and associated bone marrow may include an intraosseous (IO) needle with a removable trocar disposed therein. Various shapes and sizes of handles may be used to apply manual pressure and to manually rotate the IO needle and removable trocar as a set. Such manual IO devices often require substantial force to break through the outer cortex of a bone. Exertion of such force may cause pain to a patient and may sometimes damage the bone and/or IO device. Such force may especially cause damage when harvesting bone marrow from children with softer bone structures or from any patient with bones deteriorated by disease (osteoporosis, cancer, fractures).
Occasionally a core specimen of bone and/or bone marrow may not be successfully retrieved using a standard biopsy needle. Thus, multiple insertions at different sites may be necessary to obtain a satisfactory bone and/or bone marrow biopsy specimen. Risks to health care personnel may be higher because of increased handling of blood contaminated sharp instruments. Accidental needle sticks and missed target areas may further complicate procedures and increase risks to health care personnel and/or patients.
Conventional bone marrow transplant techniques may require multiple penetration sites (up to 20 per patient) in order to obtain enough bone marrow to perform a routine bone marrow transplant. This procedure is often labor intensive. Conventional biopsy needles and/or aspiration needles are typically inserted with considerable manual force. This force may cause loss of control or operator fatigue. When the biopsy needle or aspiration needle is in place, an associated trocar is generally removed and a syringe attached to one end of the needle to aspirate a few cubic centimeters of bone marrow. The biopsy or aspiration needle is then withdrawn. A new insertion site may be penetrated, often about a centimeter from the first insertion site. The procedure may be repeated multiple times. There is a need for better apparatus and methods for accessing bone tissue.
Vertebroplasty may often be performed with a patient sedated but awake, in a x-ray suite or an operating room. During vertebroplasty, a bone cement is typically injected under pressure directly into a fractured vertebra. Once in position, the cement may harden in about ten minutes or less, depending upon the type of cement, congealing the fragments of the fractured vertebra and providing immediate stability.